MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIBIAL ANCHOR STEM SIZE 5-6; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10011-300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smith & nephew, inc., has initiated a field action to voluntarily remove the engage cementless partial knee system from the market.This complaint was originally processed in the engage surgical complaint management system prior to acquisition by smith & nephew, inc.The event has been reassessed and is being retrospectively reported in association with the field action.Additionally, the investigation of this incident previously conducted by engage surgical has been re-opened for review.A supplemental report will be provided upon completion of further investigation activities by smith & nephew, inc.
Event or Problem Description
It was reported that, after partial right knee arthroplasty was performed on (b)(6)2020 (documented under (b)(4)), the patient experienced unexplained pain around 5-months post-operation.X-ray and ct imaging showed no evidence of patient injury or device malfunction.Implants were intact, well placed, and the surrounding bone had no evidence of damage.Ct showed good bone approximation of the implants.Even though, due to the pain, revision surgery was conducted on (b)(6)2021.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: result of investigation: in this case, there was no evidence of serious patient injury, and the surgeon may have been unaware of the existing clinical guidance medial pain related to bone remodeling for cementless uka.Investigation update: as correction action a voluntary market removal will be performed for the engage cementless partial knee system due recent complaint data that indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: TIBIAL ANCHOR STEM SIZE 5-6
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17011278
• Report Number: 1020279-2023-01145
• Device Sequence Number: 7032071
• Product Code: NJD
• UDI-Device Identifier: 00885556873106
• UDI-Public: 885556873106
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1-10011-300
• Device Lot Number: 100071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 92286
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1-10003-610, LOT: 100031; 1-10011-300, LOT: 100071; 1-10013-509, LOT:100130
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 66 KG